Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Matthew Galsky
Study ID
NCT03448718
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Urothelial Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.

Study Details

This is a single arm open label multi-institutional phase II trial of olaparib monotherapy in subjects with metastatic urothelial cancer harboring somatic DNA damage response (DDR) alterations. The primary objective of the study is to estimate the objective response rate (per RECIST 1.1) to treatment with olaparib.

Key Dates

Start date
Apr 17, 2018
Status verified
Nov 2023
Primary completion
Jul 14, 2021
Completion
Oct 15, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib Monotherapy
    The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to a maximum of 17 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Karmanos Cancer Center (Wyane State University)DetroitMichigan48201-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-6542-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Vanderbilt-Ingran Cancer CenterNashvilleTennessee37232-
Huntsman Cancer Institute University of UtahSalt Lake CityUtah84112-5550-

Find similar trials in Chicago, IL

By research site
University of Chicago Medical Center· Chicago, ILJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDKarmanos Cancer Center (Wyane State University)· Detroit, MIIcahn School of Medicine at Mount Sinai· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCVanderbilt-Ingran Cancer Center· Nashville, TN

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